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This is great news, although the expense of the drug currently will limit its usefulness as a prevention tool in the US. Will insurance companies cover it for HIV negative people? As I recall the patent doesn't expire until 2018. Perhaps if Gilead sees a larger market here, the price could come down significantly. Afterall, a 73% reduction in transmissions is almost comparable to what a viable vaccine candidate needs to aim for.

Scientists have an exciting breakthrough in the fight against AIDS. A pill already used to treat HIV infection turns out to be a powerful weapon in protecting healthy gay men from catching the virus, a global study found.

Daily doses of Truvada cut the risk of infection by 44 percent when given with condoms, counseling and other prevention services. Men who took their pills most faithfully had even more protection, up to 73 percent.

Researchers had feared the pills might give a false sense of security and make men less likely to use condoms or to limit their partners, but the opposite happened — risky sex declined.The results are "a major advance" that can help curb the epidemic in gay men, said Dr. Kevin Fenton, AIDS prevention chief at the U.S. Centers for Disease Control and Prevention. But he warned they may not apply to people exposed to HIV through male-female sex, drug use or other ways. Studies in those groups are under way now.

The news came as UNAIDS announced that the global epidemic was slowing — new cases dropped nearly 20 percent over the last decade and about 33 million people are living with HIV now. Health officials credit part of the decline to wider condom use, and on Tuesday the Vatican said that using a condom is a lesser evil than infecting a sexual partner with HIV — further expanding what some see as Pope Benedict XVI's softening stance on this issue.

"This is a great day in the fight against AIDS ... a major milestone," said a statement from Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition, a nonprofit group that works on HIV prevention.Because Truvada is already on the market, the CDC is rushing to develop guidelines for doctors using it for HIV prevention, and urged people to wait until those are ready.

"It's not time for gay and bisexual men to throw out their condoms," Fenton said. The pill "should never be seen as a first line of defense against HIV."

As a practical matter, price could limit use. The pills cost from $5,000 to $14,000 a year in the United States, but only 39 cents a day in some poor countries where they are sold in generic form.

Whether insurers or government health programs should pay for them is one of the tough issues to be sorted out, and cost-effectiveness analyses should help, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

"This is an exciting finding," but it "is only one study in one specific study population," so its impact on others is unknown, Fauci said.

His institute sponsored the study with the Bill & Melinda Gates Foundation. Results were reported at a news conference Tuesday and published online by the New England Journal of Medicine.It is the third AIDS prevention victory in about a year. In September 2009, scientists announced that a vaccine they are now trying to improve had protected one in 3 people from getting HIV in a study in Thailand. In July, research in South Africa showed that a vaginal gel spiked with an AIDS drug could cut nearly in half a woman's chances of getting HIV from an infected partner.

Gay and bisexual men account for nearly half of the more than 1 million Americans living with HIV. Worldwide, more than 7,000 new infections occur each day. Unlike in the U.S., only 5 to 10 percent of global cases involve sex between men.

"The condom is still the first line of defense," because it also prevents other sexually spread diseases and unwanted pregnancies, said the study leader, Dr. Robert M. Grant of the Gladstone Institutes, a private foundation affiliated with the University of California, San Francisco.

But many men don't or won't use condoms all the time, so researchers have been testing other prevention tools.

AIDS drugs already are used to prevent infection in health care workers accidentally exposed to HIV, and in babies whose pregnant mothers are on the medication. Taking these drugs before exposure to the virus may keep it from taking hold, just as taking malaria pills in advance can prevent that disease when someone is bitten by an infected mosquito.

The strategy showed great promise in monkey studies using tenofovir (brand name Viread) and emtricitabine, or FTC (Emtriva), sold in combination as Truvada by California-based Gilead Sciences Inc.The company donated Truvada for the study, which involved about 2,500 men at high risk of HIV infection in Peru, Ecuador, Brazil, South Africa, Thailand and the United States (San Francisco and Boston). The foreign sites were chosen because of high rates of HIV infection and diverse populations.More than 40 percent of participants had taken money for sex at least once. At the start of the study, they had 18 partners on average; that dropped to around 6 by the end.

The men were given either Truvada or dummy pills. All had monthly visits to get HIV testing, more pills and counseling. Every six months, they were tested for other sexually spread diseases and treated as needed.After a median followup of just over a year, there were 64 HIV infections among the 1,248 men on dummy pills, and only 36 among the 1,251 on Truvada.

Among men who took their pills at least half the time, determined through interviews and pill counts, the risk of infection fell by 50 percent. For those who took pills on 90 percent or more days, risk fell 73 percent. Tests of drug levels in the blood confirmed that more consistent pill-taking gave better protection.The treatment was safe. Side effects were similar in both groups except for nausea, which was more common in the drug group for the first month but not after that. Unintended weight loss also was more common in the drug group, but it occurred in very few. Further study is needed on possible long-term risks.

What's next?

All participants will get a chance to take Truvada in an 18-month extension of the study. Researchers want to see whether men will take the pill more faithfully if they know it helps, and whether that provides better protection. About 20,000 people are enrolled in other studies testing Truvada or its component drugs around the world.

The government also will review all ongoing prevention studies, such as those of vaccines or anti-AIDS gels, and consider whether any people currently assigned to get dummy medicines should now get Truvada since it has proved effective in gay men.

Gilead also will discuss with public health and regulatory agencies the possibility and wisdom of seeking approval to market Truvada for prevention. The company has made no decision on that, said Dr. Howard Jaffe, president of Gilead Foundation, the company's philanthropic arm. Doctors can prescribe it for this purpose now if patients are willing to pay for it, and some already do.

Some people have speculated that could expose Gilead to new liability concerns, if someone took the pill and then sued if it did not protect against infection.

"The potential for having an intervention like this that has never been broadly available before raises new questions. It is something we would have to discuss internally and externally," Jaffe said.Until the CDC's detailed advice is available, the agency said gay and bisexual men should:—Use condoms consistently and correctly.—Get tested to know their HIV status and that of their partners, and get tested and treated for syphilis, gonorrhea and other infections that raise the risk of HIV.—Get counseling to reduce drug use and risky sex.—Reduce their number of sexual partners.

I wish these three threads could be merged, cause this NYT article answers some of my questions about the more PR article in the first thread. 90% effective. Great. But that still leaves 10%.But nice to see it wasnt paid for by the drug companies.

Who are these doctors "regularly" prescribing it, by the way? And the patient's insurance pays?

My insurance doesn't pay for erection pills.

That would be a bummer for the HIV- party boy. All truvada'd up for the big sex party where he'll "lose his inhibitions", but since tanked up on booze and drugs, can't get it up to even screw!

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“From each, according to his ability; to each, according to his need” 1875 K Marx

My question is: how do the researchers really know the pills were the reason for ower infection rate, as opposed to increase condom use? This sounds to me like selective cheering on the researchers' part, much like the misleading Thailand study, IMO.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

I've been wondering this as well. At the outset, you'll be told its because BOTH the control and the experimental group received the same counseling, and the experimental group clearly had a lower rate of infection. What I note in the study is the fact that the effectiveness of the drug increased with its adherence. Its not much of a stretch to think that the usage of condoms probably also increased with antiretroviral adherence too, meaning that the drugs may not be as amazing as they appear. This may be why everyone is reporting that the drugs reduce infection by 40%, rather than the 95% reduction you see in those deemed maximally adherent.

I wonder if, despite the counseling, any of the participants rarely or never used condoms, and if the researchers have results for those groups.

Having to take the med 365 days a year preventatively is still too expensive for most people. It would be nice if the studies could narrow down the effectiveness of when it's necessary to take the med (say, how many days before sex, and how many days after) and still benefit, thus not having long-term side effects, and lowering the cost.

I doubt insurance companies will cover PrEP. They already don't cover condoms which are more effective and cheaper.

J220 said My question is: how do the researchers really know the pills were the reason for lower infection rate, as opposed to increased condom use? This sounds to me like selective cheering on the researchers' part, much like the misleading Thailand study, IMO.

I agree with this. Sounds more like a plug for Truvada and the pharmaceutical company than Truvada actually reducing transmission. IMHO

I know for myself, after learning I can get hepatitus A & B, Tuburculosis, Mono, Strep Throat, All sorts of STDs and STIs from some other person who is DD free "drug and disease free" lol. And I signed a piece of paper with the state health department that I'm aware I'm HIV positive and my stats went to the CDC, I'm sure as heck not going to be slinging my dick or ass around without a condom.

The only thing that I can imagine Truvada helping is the viral load. And theoretically if the viral load is lower, it's harder to transfer the virus. But I'm a newbie and don't really know much. It's just logical. Have a Happy Thanksgiving.

Granny60

I agree with this. Sounds more like a plug for Truvada and the pharmaceutical company than Truvada actually reducing transmission. IMHO

I know for myself, after learning I can get hepatitus A & B, Tuburculosis, Mono, Strep Throat, All sorts of STDs and STIs from some other person who is DD free "drug and disease free" lol. And I signed a piece of paper with the state health department that I'm aware I'm HIV positive and my stats went to the CDC, I'm sure as heck not going to be slinging my dick or ass around without a condom.

The only thing that I can imagine Truvada helping is the viral load. And theoretically if the viral load is lower, it's harder to transfer the virus. But I'm a newbie and don't really know much. It's just logical. Have a Happy Thanksgiving.

And what about the other 27%. That's still 27% of transmissions!?!

And don't forget Hep C which can be a real nasty bugger and there is no vaccine for it.

If Truvada can be used as a preventative measure, does anyone know if it could be used solo or if there is any research in that area (I can't find any). I remember watching a video somewhere about the rationale behind a 3 drug cocktail, but don't completely remember the science behind it. Would be great to drop the Issentress and just need to take one Truvada a day. I'm all for fewer pills (not that those two are a major pain or anything). Fewer is better in my book

If Truvada can be used as a preventative measure, does anyone know if it could be used solo or if there is any research in that area (I can't find any). I remember watching a video somewhere about the rationale behind a 3 drug cocktail, but don't completely remember the science behind it. Would be great to drop the Issentress and just need to take one Truvada a day. I'm all for fewer pills (not that those two are a major pain or anything). Fewer is better in my book

Try it and find out sweetheart. I guarantee if you switch to just a two NRTI med regimen to treat a present HIV infection you'll likely end up with multiple resistance issues like what I got when I was on such a regiment from 1993-1996, because that's all that was around then.

Try it and find out sweetheart. I guarantee if you switch to just a two NRTI med regimen to treat a present HIV infection you'll likely end up with multiple resistance issues like what I got when I was on such a regiment from 1993-1996, because that's all that was around then.

I wasn't implying that I was going to experiment with anything, darling. I asked the question because I was looking for some information. From 1993-1996, there wasn't talk of using Truvada for prevention because, of course, it didn't exist.

I wasn't implying that I was going to experiment with anything, darling. I asked the question because I was looking for some information. From 1993-1996, there wasn't talk of using Truvada for prevention because, of course, it didn't exist.

So, based on that, once you've got it the third component does something that is not needed to prevent infection? Any idea as to what that third component does that is not needed for prevention? Assumably, it does something within a cell?

I remember watching a video somewhere about the rationale behind a 3 drug cocktail, but don't completely remember the science behind it.

aidsmeds has the great lessons about all sorts of stuff. the Lesson on the life cycle of HIV (http://www.aidsmeds.com/articles/hiv_life_cycle_5014.shtml) explains why a multi-pronged approach (entry inhibitors, Reverse transcription blockers, integrase inhibitors, Maturation Inhibitors) is needed to halt HIV replication. HIV is a very durable virus and unless attacked on multiple fronts, it easily mutates to a stronger strain once again able to replicate. (and hence why multi-drug adherence of is such extreme importance)

Zorro - Phil's right about getting up to speed on the details and taking advantage of the lessons on AIDSmeds. We work really, really hard trying to cover everything out there in the world of treatment, care and new research. As a result, our website is pretty thorough and if you can't find the answer you're looking for through our navigation, then try searching. Worst case scenario, if you're not finding what you need on AIDSmeds, then post your question in the forum, but ask if someone is aware of where you can find the answer and get educated (on AM or elsewhere). It shows that you're willing to do the work--and the reading--to get educated.

Lastly, you do have a point Zorro. People are already thinking about drugs like Selzentry (maraviroc) for PrEP. They've been holding back on that research, because the Truvada and Viread trials were already recruiting in many cases and we needed to make sure that the concept had promise before spending a lot of money trying something else without the benefit of the results of the first PrEP trials.

I would suspect that researchers are likely to rush forward with more monkey studies of Selzentry now and ultimately with a human study, but that's likely going to take a few years to generate results.

I'm still trying, though, to understand how Truvada can be effective as a preventative agent by itself but requires a third component to remain effective as treatment. I guess I'm a little slow on the uptake (I hated Chemistry in school). If it works from inside a cell, then presumably, it is preventing infection from within the cell. How would that be any different before or after infection?

I'm working Google but I'm not finding anything other than it's required to be taken with something else...

I'm still trying, though, to understand how Truvada can be effective as a preventative agent by itself but requires a third component to remain effective as treatment. I guess I'm a little slow on the uptake (I hated Chemistry in school). If it works from inside a cell, then presumably, it is preventing infection from within the cell. How would that be any different before or after infection?

I'm working Google but I'm not finding anything other than it's required to be taken with something else...

Well... first of all, it wasn't 100% effective as a preventative agent. Some people still got infected.

Second, and more importantly though, is that once someone is infected and trying to use Truvada as treatment they have a reservoir of infected cells where HIV is reproducing and generating a constant stream of HIV infection. Each time HIV reproduces is an opportunity for mutation, and the constant pressure of Truvada provides a huge advantage for HIV mutants that are immune to Truvada to be selected and thrive.

When Truvada is used as a preventative, the stream of potential infection is episodic rather than constant. And until HIV takes hold it doesn't reproduce and start to mutate. Resistance is a product of HIV mutating and HIV mutations almost always occur during reproduction. Reproduction occurs after HIV has secured a foot-hold, not before...

Well... first of all, it wasn't 100% effective as a preventative agent. Some people still got infected.

good point, of course.

I think I'm going to have to talk to my ID about this because without someone drawing me a picture or something, I don't think I'm gonna "get it"

I just can't seem to get my head around how, if it (Truvada), enters a cell and then defeats HIV as a preventative treatment it would react any differently to any HIV that would be produced from a reservoir (or any other source). It's still going to penetrate the cell and do what it does. If the biggest reason is mutations and resistance, then wouldn't that indicate that despite reaching UD, resistance will utlimately develop to Truvada in the eventuality that the reservoirs start to propogate? Or, maybe that's what the third component does?

Mutant virus is often less fit (easier to kill / may take longer to kill you) than the wild type. But the reason for multiple drugs is so that when your first line of defense falls to a particular mutation, you have a second line.

Okay, so riddle me this: does that mean that the Truvada could basically end up failing as a result of a mutant strain? If that's the case, I would effectively be relying on Issentress monotherapy then, right? Or is the intent that the Issentress would wipe out whatever Truvada can't deal with and one is basically back at "start" waiting for any additional virus that might rear its ugly head?

Do you know if the doctors have the ability to monitor whether a portion of the cocktail has failed as a result of mutant virus or does one have to wait for everything to fail as evidenced by a viral load spike and then do resistance testing?

Do you know if the doctors have the ability to monitor whether a portion of the cocktail has failed as a result of mutant virus or does one have to wait for everything to fail as evidenced by a viral load spike and then do resistance testing?

an increasing viral load (over several tests to rule out a random spike) is the evidence of drug (one or more, not neccasarily "everything") failure, so that is exactly what you are being monitored for already. Once you have that increasing viral load, and it reaches a certain point then resistance testing can be done (i believe the test has been done at least 1000 vl, though there is evidence that the test is also reliable at lower levels) to determine which med is no longer viable against the HIV.

Truvada (and perhaps other meds) can potentially prevent the virus from taking hold in a preventative way because there is (in all likelihood) a single strain that the med can destroy before it has a chance to settle into the reservoirs where it can reproduce. During the reproduction, it's possible (probable?) that mutant strains will be produced. These mutant strains could potentially be resistant to Truvada which is where the other med comes in for treatment...it's the "backup".

I wonder if any additional research was done for those who were infected despite taking preventative Truvada to determine whether or not the strain that infected them was already resistant to Truvada. I'm sure it must have been as one would expect the researchers to want to determine why the PrEP failed.

Truvada (and perhaps other meds) can potentially prevent the virus from taking hold in a preventative way because there is (in all likelihood) a single strain that the med can destroy before it has a chance to settle into the reservoirs where it can reproduce. During the reproduction, it's possible (probable?) that mutant strains will be produced. These mutant strains could potentially be resistant to Truvada which is where the other med comes in for treatment...it's the "backup".

I wonder if any additional research was done for those who were infected despite taking preventative Truvada to determine whether or not the strain that infected them was already resistant to Truvada. I'm sure it must have been as one would expect the researchers to want to determine why the PrEP failed.

Again, thanks for the input and your patience.

~ Z

As I am sure you are aware, Truvada is more than a single medicine. That's the trick. A good one-two punch

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"Many people, especially in the gay community, turn to oral sex as a safer alternative in the age of AIDS. And with HIV rates rising, people need to remember that oral sex is safer sex. It's a reasonable alternative."

As I am sure you are aware, Truvada is more than a single medicine. That's the trick. A good one-two punch

yup, but thanks, JK.

I guess this all just underscores how important it is to figure out how to flush the latent virus from the reservoirs Let's hope the researchers are better at doing that than we have been about flushing Bin Laden from his cave.

I know its splitting hairs, but why isn't it the "War on HIV" and not AIDS, and why isn't this headline "An Advance in HIV Treatment".

And why isn't this forum called HIVMEDS........

why why why

There is something in the answer that could help explain the weird excitement about this development that to me personally seems kind of a snooze. I mean Bravo if prep can help sex workers and what ever other specific population avoid HIV infection, but I don't think Id even consider taking it if I was HIV- and with an HIV+ bf. I mean dont a lot of people end up with HIV from accidents and poor decisions that therefore have no chance of being prevented by PREP which by its nature is pre planning???

And if I were an HIV- gay sex pig taking PREP in order to party, then I certainly wouldn't bother with condoms. And If were going to use condoms, than i would consider PREP overkill and obsessive compulsive to the point I shouldnt be doing something that I was worried a risk...

« Last Edit: November 28, 2010, 07:40:33 PM by mecch »

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“From each, according to his ability; to each, according to his need” 1875 K Marx

I mean Bravo if prep can help sex workers and what ever other specific population avoid HIV infection, but I don't think Id even consider taking it if I was HIV- and with an HIV+ bf. I mean dont a lot of people end up with HIV from accidents and poor decisions that therefore have no chance of being prevented by PREP which by its nature is pre planning???

And if I were an HIV- gay sex pig taking PREP in order to party, then I certainly wouldn't bother with condoms. And If were going to use condoms, than i would consider PREP overkill and obsessive compulsive to the point I shouldnt be doing something that I was worried a risk...

A perfectly reasonable response. I've said it before, and I'll say it again, the only people who will really benefit from PREP are those who knowingly and regularly place themselves at risk and have huge sums of money to throw away for the privilege of remaining negative. Its all good and well to say "everyone has the right to remain HIV negative" as Project Inform has done, but frankly, these are the people who least deserve access to scare medical resources. It'll help those who know better but want to "walk on the wild side", and are actually lame enough to plan their little foray into danger weeks in advance. Any normal human being who becomes infected...will still become infected. Its not going to help anyone whose partner lied. Its not going to help people who makes normal human screwups. Its not going to help condom users who have breaks. Intentional infections are still gonna be an issue. Its not even going to help sex workers or prisoners. We can't even get these people condoms, why the hell would we think its feasible to get them access to preventative HAART which has to be taken religiously?

I have a partner who I very much want to remain negative. I appreciate the fact that there is one more tool available to do this, but we're both pretty much in agreement that this stuff is gonna be a pain in the ass to pay for. I assume American insurance companies will fight it tooth and nail, and European health agencies will ignore it altogether. Prep is basically an option for gay men who want to spend their Friday nights in a sling in the bathhouse. Those who have the most money to throw away on this "miracle" will be the ones who benefit from it the most as its benefit is correllated with the regularity of its usage. Congratulations, money might not cure AIDS as Southpark once joked, but it now sure as hell prevents it. What a horriffic fucking world we live in.

Finally, I'm deeply concerned about what this is going to do to the rate of resistant strains that are floating around out there. The dark underbelly to this study is that there was a rather profound adherence problem amongst the group studied. Some days they took it. Some days they didn't. The researchers basically had to count their pills and test their blood to see whether or not the experimental group was really taking their meds. Its been stated already that adherence in clinical trials is usually higher than in real life, and I can't imagine that the added cost that will be associated with Prep in real life is going to help that problem. Its not unreasonable to believe that Prep might result in an explosion of risky behavior and a commensurate rise in medication-resistant infections. Given Truvada's place as the first line drug of choice for a lot of regimes, it seems a tragic to squander it so that a few sex pigs in investment banking can live a consequence-free lifestyle.

EDIT: And god forbid anyone in this discussion would interrupt their celebration about this stuff, but where exactly is the outrage that nearly 4000 poor americans are languishing on ADAP waiting lists while the NIH funds a drug study which is mostly going to benefit the obscenely wealthy?

but where exactly is the outrage that nearly 4000 poor americans are languishing on ADAP waiting lists while the NIH funds a drug study which is mostly going to benefit the obscenely wealthy?

good point, and as of nov 19, 2010, there are 4,109 person on the waiting lists of 9 states. Although many of those people are receiving meds, they are getting those meds through non-traditional and temporary measures - measures which could just as easily dry up or be defunded.

In reply to Mecch: I have a slight issue with the word AIDS, it just seems extremeinly politically correct especially when you're talking about people who are hiv+ and do not have AIDS. For most people however the two are interchangeable.

Truvada (and perhaps other meds) can potentially prevent the virus from taking hold in a preventative way because there is (in all likelihood) a single strain that the med can destroy before it has a chance to settle into the reservoirs where it can reproduce. During the reproduction, it's possible (probable?) that mutant strains will be produced. These mutant strains could potentially be resistant to Truvada which is where the other med comes in for treatment...it's the "backup".

Probable. HIV is particularly likely to throw off mutants during reproduction. Many fail to "live" (if you consider a virus as living) and the vast majority fail to thrive. But it throws off a lot of them and some make it.

Probable. HIV is particularly likely to throw off mutants during reproduction. Many fail to "live" (if you consider a virus as living) and the vast majority fail to thrive. But it throws off a lot of them and some make it.